Rompe Pecho

Product NDC
58593-829
11-digit product format
585930829
Labeler code
58593
Product ID
58593-829_26e4f72a-b911-8dc6-e063-6394a90a4326
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Efficient Laboratories Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-01
Substance
GUAIFENESIN
Active strength
200 mg/10mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rompe Pecho
Brand name suffix
EX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310604, 1112205

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58593-829-042023-08-03C16284748780-10191ceaa-6550-198a-e063-dbdaa90aec3eDrug Facts
58593-829-062023-08-03C16284748780-10191ceaa-6550-198a-e063-dbdaa90aec3eDrug Facts
58593-829-042023-07-28C16284748780-10191ceaa-6550-198a-e063-dbdaa90aec3eDrug Facts
58593-829-062023-07-28C16284748780-10191ceaa-6550-198a-e063-dbdaa90aec3eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-829-04Rompe PechoEX118 mL in 1 BOTTLELIQUID11812
58593-829-06Rompe PechoEX178 mL in 1 BOTTLELIQUID17812

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
GUAIFENESINACTIVE MOIETY495W7451VQROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
ASCLEPIAS TUBEROSA ROOTINACTIVE INGREDIENT1ZL82U5D18ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
CAULOPHYLLUM THALICTROIDES ROOTINACTIVE INGREDIENTJTJ6HH6YEHROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DXROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
GINKGOINACTIVE INGREDIENT19FUJ2C58TROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JVROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
HONEYINACTIVE INGREDIENTY9H1V576FHROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
HOREHOUNDINACTIVE INGREDIENTK08036XEJVROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
MYRRHINACTIVE INGREDIENTJC71GJ1F3LROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
PRUNUS SEROTINA BARKINACTIVE INGREDIENT5D48E975HAROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
ULMUS RUBRA BARKINACTIVE INGREDIENT91QY4PXU8QROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
VERBASCUM DENSIFLORUM LEAFINACTIVE INGREDIENT9936O846LIROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
WATERINACTIVE INGREDIENT059QF0KO0RROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TBROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-829ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]12Current NDC, Legacy NDC, 2 package rows20241116_89ea23a5-0da7-407e-83d9-77a0b562f3af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN89ea23a5-0da7-407e-83d9-77a0b562f3af12
1112205Rompe Pecho 100 MG in 5 mL Oral SolutionPSN89ea23a5-0da7-407e-83d9-77a0b562f3af12
1112205guaifenesin 20 MG/ML Oral Solution [Rompe Pecho]SBD89ea23a5-0da7-407e-83d9-77a0b562f3af12
310604guaifenesin 20 MG/ML Oral SolutionSCD89ea23a5-0da7-407e-83d9-77a0b562f3af12
310604guaifenesin 100 MG per 5 ML Oral SolutionSY89ea23a5-0da7-407e-83d9-77a0b562f3af12
310604guaifenesin 100 MG per 5 ML Oral SyrupSY89ea23a5-0da7-407e-83d9-77a0b562f3af12
310604guaifenesin 200 MG per 10 ML Oral SolutionSY89ea23a5-0da7-407e-83d9-77a0b562f3af12
310604guaifenesin 300 MG per 15 ML Oral SolutionSY89ea23a5-0da7-407e-83d9-77a0b562f3af12
310604guaifenesin 400 MG per 20 ML Oral SolutionSY89ea23a5-0da7-407e-83d9-77a0b562f3af12
1112205Rompe Pecho 100 MG per 5 ML Oral SolutionSY89ea23a5-0da7-407e-83d9-77a0b562f3af12
1112205Rompe Pecho 20 MG/ML Oral SolutionSY89ea23a5-0da7-407e-83d9-77a0b562f3af12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58593-829-0458593082904118 mL in 1 BOTTLE (58593-829-04) 118 ml2019-04-010000-00-00NoNoCurrent
58593-829-0658593082906178 mL in 1 BOTTLE (58593-829-06) 178 ml2015-01-010000-00-00NoNoCurrent